BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 16990213 · Received May 24, 2023

    Report

    Report Number
    3006630150-2023-02907
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    November 17, 2020
    Report Date
    May 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE OF YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5180145 / 5180313.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) DEVICE WAS CAUSING DISCOMFORT AND WAS NO LONGER TAKING A CHARGE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698011 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 354531 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention